Kornimate/medical-research-clean huggingface dataset:
sepsis post market clinical utility simple endpoint study - humc

Conditions: Sepsis; Adult Disease; Emergency Department; Severe Sepsis

Summary: the purpose of this study is to demonstrate that addition of the monocyte width distribution (mdw) parameter to current standard of care improves a clinician's ability to recognize sepsis in the emergency department, resulting in earlier decision to administer antibiotics from time of ed presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

the objective of this study is to develop a method for identifying sepsis patients from electronic health records (ehr) based on sepsis-2 criteria. sepsis patients will be identified using a sepsis definition which includes meeting sirs score of ≥2 within 12 hours of ed presentation and any microbial testing ordered within 24 hours of ed presentation. the patient will be enrolled if it meets the sepsis definition and additional emr data elements will be extracted to complete case report form. furthermore, objectives include to confirm the clinical validity and performance of mdw in a control population of sepsis patients where mdw is measured but not reported to physicians. this study is an observational study which will simulate the decision impact of mdw on sepsis identification and patient management.

Eligibility criteria:
inclusion criteria: * adult (18 to 89 years) * all race and ethnicities * presenting to the emergency department with suspicion of infection * whose assessment includes a cbc with differential * meets emr sepsis definition exclusion criteria: * pregnancy * prisoners * transfers from other ed * previously enrolled
cervical arthroplasty "fixed core" versus "movable core": clinical and radiological impact in the medium term

Conditions: Neck Pain; Back Pain

Summary: nowadays, there is no clinical and radiological study comparing two different types of mobile implants in patients requiring surgical treatment for symptomatic cervical disc disease. thus, the choice of the ideal implant remains uncertain. the goal of this work is to compare the impact of two types of mobile implants in height drives, solicitation facets, positioning and collection of prostheses within the intervertebral spaces.


Eligibility criteria:
inclusion criteria: * age \> 18 years * symptomatic cervical disc degenerative pathologies to 1 or more contiguous or non-contiguous levels c3-4 to c6-7. * symptoms including: cervicobrachial neuralgia and / or loss of root muscle strength and / or sensory impairment and paresthesia and / or cervical myelopathy table * concordant diagnosis confirmed by ct (computerized tomography scanner) and mri (magnetic resonance imaging) of the cervical spine * npds (neck pain and disability scale) \> 30 * failure to respond to conservative medical treatment for 6 weeks or worsening symptoms despite conservative treatment * physical and mental fitness to ensure compliance with the protocol * signed informed consent exclusion criteria: * unstable cervical spine injuries requiring fusion c1 to c7 for whatever the etiology, proven on dynamic views of the cervical spine * paget's disease, osteomalacia, other metabolic bone diseases * chronic corticosteroid use * active tumor pathology * segmental angulation \ 11 ° at the respective segment or adjacent segments on static images of the cervical spine * known allergy to chromium, cobalt, mobdylene (chemical element), polyethylene, or titanium * history of surgery in the previous 30 days before inclusion * history of mental illness or disability involving a "safeguard procedure justice of the person" * contraindications to non steroidal anti inflammatory

Keywords: cervical arthroplasty
a study of single-agent at-101 in men with hormone refractory prostate cancer

Conditions: Hormone Refractory Prostate Cancer

Summary: this is an open-label, multicenter phase i/ii study to evaluate the safety and efficacy of single-agent at-101 in men with hormone-refractory prostate cancer.


Eligibility criteria:
inclusion criteria: 1. rising psa, as defined by increasing levels on at least two consecutive assessments 2. ecog performance status 0 or 1 3. adequate hematologic function 4. adequate liver and renal function 5. able to swallow and retain oral medication. exclusion criteria: 1. received prior chemotherapy for hrpc. 2. concurrent therapy for the treatment of prostate cancer. 3. clinical signs or symptoms of cns metastases 4. requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease. 5. active secondary malignancy or history of other malignancy within the last 5 years. 6. failure to recover from toxicities related to prior therapy. 7. uncontrolled concurrent illness.
online interventions for gamblers with and without co-occurring problem drinking

Conditions: Gambling; Alcohol Consumption

Summary: many problem gamblers are also problem drinkers,with lifetime prevalence in nationally representative samples ranging from 45% to 73%. heavy drinking often occurs while problem gamblers are engaging in gambling activities, resulting in increased risky gambling behaviour. further, co-occurring problem drinking negatively impacts on the treatment outcomes of problem gamblers. thus, targeting problem drinking among problem gamblers may have the dual benefits of reducing both the problem drinking itself, and of acting as a mediator for reductions in problem gambling behaviour. the present study seeks to determine whether providing simultaneous access to help for gambling and drinking is of benefit for those with these co-occurring problems.

problem gambling and problem drinking frequently co-occur. further, the treatment needs of people with co-occurring gambling and drinking problems may be different from those of problem gamblers who do not drink alcohol in a hazardous fashion. the current project will evaluate whether there is a benefit to providing access to a problem drinking internet intervention (g+a intervention) in addition to an internet intervention for problem gambling (g-only intervention) in participants with gambling problems who do or do not have co-occurring problem drinking. people with gambling concerns will be recruited using targeted advertisements. potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. as part of the baseline screening process, measures of alcohol consumption will be assessed. eligible participants who agree to take part in the study will be randomized into one of two online interventions for gamblers - an intervention that only targets gambling issues (g-only) versus one that contains an intervention for drinking (g+a). it is predicted that for problem gamblers with co-occurring problem drinking, participants provided access to the g+a website will display significantly reduced gambling outcomes at three- and six-month follow-ups as compared to those provided access to the g-only website. however, for problem gamblers without co-occurring problem drinking, it is predicted that participants will display no significant difference between the g-only and g+a websites at three- and six-month follow-ups.

Eligibility criteria:
inclusion criteria: * 18 years of age or over * score of 3 or greater on the problem gambling severity index of the canadian problem gambling index (pgsi- cpgi) exclusion criteria: * none
urolift system tolerability and recovery when administering local anesthesia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of the study is to evaluate procedure tolerability and surgical recovery following the urolift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (bph). primary effectiveness will be achieved by looking at the quality of recovery visual analog scale (qor vas) by the one month follow-up visit.

the randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the urolift® system procedure when conducted with local anesthesia. all subjects undergo urolift system treatment and will be followed through 5 years after receiving the investigational device.

Eligibility criteria:
inclusion criteria: * males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (bph) exclusion criteria: * size, volume,length of prostate

Keywords: urolift system
a first-in-human clinical trial to evaluate the safety, tolerability, and efficacy of a novel crispr rna-editing therapy in patients with mecp2 duplication syndrome, a rare orphan disease (hero)

Conditions: MECP2 Duplication Syndrome

Summary: methyl-cpg binding protein 2 (mecp2) is a dosage-sensitive, x-linked gene critical for central nervous system development and functional maintenance, which gain-of-function causes mecp2 duplication syndrome (mds). affecting primarily in males, this disorder is characterized by severe intellectual disability, motor dysfunction, infantile hypotonia, epilepsy, respiratory tract infections, and premature death before 25 years of age with no curative therapy. hg204 is a crispr rna-editing therapy packaging novel high-fidelity cas13y (hfcas13y) technology, using one single adeno-associated virus (aav) vector to target and knock down mecp2 mrna in the brain. preclinical studies showed that a single intracerebroventricular injection of hg204 persistently decreased mecp2 mrna and mecp2 protein in the cortex of the mds mice, reversed the abnormal motor and social phenotypes, and significantly prolonged survival in mds mouse models.


Eligibility criteria:
inclusion criteria: * males ≥ 2 and ≤18 years at the time of signing informed consent; * genetic test and clinical confirmed diagnosis of mds; * stable pattern of seizures, or has had no seizures while currently receiving medical treatment (including antiepileptics) and physical therapy are stable for at least 2 months before screening; * willing to adhere to protocol, including biological samples collection and hospitalization for intracerebroventricular injection surgery; * acceptable hematology, clinical chemistry, and urine laboratory parameters. exclusion criteria: * mecp2 gene triplication; * concurrent genetic syndromes other than mds; * significant brain or cerebellar atrophy, or other significant degenerative changes as shown in cranial mri at screening; * prior or current hypertension, cardiomyopathy, myocardial ischemia or atrial fibrillation and other cardiovascular diseases; * prior central nervous system surgery within 6 months before enrolment; * systemic use of immunosuppressive drugs within 3 months before enrolment; * prior gene therapy or oligonucleotide therapy treatments; * any other conditions that would not allow the potential subject to complete follow-up examinations during the study and would, in the opinion of the investigator, make the potential subject unsuitable for the study.

Keywords: mecp2 dupmecp2 cns neurodevelopmental disease gene-editing hg204 crispr mds
trial to evaluate the efficacy of topical capsaicin to reduce pain and improve health-related quality of life in adults with chronic myofascial neck pain

Conditions: Myofascial Pain Syndrome

Summary: chronic neck pain is a common condition that can negatively impact quality of life. substance p is one of the chemicals in the body that can transmit pain signals from overloaded neck muscles to the brain. topical capsaicin blocks the action of substance p by releasing, and subsequently depleting the body's store of substance p in the nerves. topical capsaicin has been reported to be an effective therapy for a number of persistent pain conditions including diabetic neuropathy, post-herpetic neuralgia, osteoarthritis, rheumatoid arthritis, and post-mastectomy pain. this study will evaluate the efficacy of topical capsaicin to reduce pain and improve health-related quality of life in adults with chronic muscular neck pain.

the study will employ a double blinded randomized controlled cross-over trial design. a total of 60 patients aged 18-65 with at least 3 months of myofascial neck pain will be recruited to participate in the study. the participants will be randomized into two groups. each group will undergo two 4-week treatment arms separated by a 4-week wash-out period. participants will apply a topical gel patch 12 hours each day overlying painful areas in the neck and shoulder girdle for each 4-week period. the topical gel patch used in each arm of the study will be identical except the placebo will not contain the active ingredient, 0.1% capsaicin. both topical gel patches will be supplied by caleb pharmaceuticals. each participant will complete 3 surveys at baseline and after each 4-week treatment arm: 1) mcgill pain scale, 2) visual analog scale, and 3) short form 36 (general quality of life data). paired t-tests will be used to evaluate for statistically significant changes between treatment with the control gel versus the active ingredient gel containing the capsaicin.

Eligibility criteria:
inclusion criteria: * adults over 18 years of age * speak, read, and write english who have greater than 3 month duration of myofascial neck pain. exclusion criteria: * patients who have used capsaicin in the last 4 months and patients with allergy to capsaicin * rash/infection overlying neck and shoulder girdle area * radiculopathy or structural abnormalities in the area being treated * unstable underlying diseases such as cardiovascular, hepatic, renal and cns disorders will be excluded from the study * pregnant or breast-feeding women will not be allowed to participate in the study, and women of child bearing age will be using an effective method of birth control.

Keywords: capsaicin hydrogel myofascial pain syndrome neck pain
the effects of a prostaglandin inhibitor on ovulation and the menstrual cycle

Conditions: Ovulation (Follicular Rupture Yes/no); Menstrual Cycles (Total Length, Bleeding Days); Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)

Summary: the investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.

currently available methods of emergency contraception (ec) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. women having unprotected sex outside this window receive no benefits from this emergency therapy. prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an ec effect that works over a longer time period. we wanted to determine if celecoxib might work as an ec with a wider window of action.

Eligibility criteria:
inclusion criteria: * age 18-35 * normal menstrual periods (24-35 days) * good general health * willing to use a non-hormonal form of contraception for the entire study (acceptable forms of contraception include condoms, spermicide, sexual contact with a sterilized partner, subject is surgically sterile, same-sex partner, copper iud and abstinence) * willing and able to return to clinic for bi-weekly blood tests exclusion criteria: * pregnant or breast feeding * polycystic ovarian disease * gastrointestinal conditions (i.e.gastric ulcer) * currently using birth control * known allergy to aspirin, non-steroidal anti-inflammatory drugs (nsaids) or sulfa-drugs * diabetes * cardiac disease or hypertension * moderate to severe heartburn (gerd) * obesity (bmi greater than 30)

Keywords: celebrex prostaglandin inhibitor ovulation menstrual cycles
comparison of avf versus avg in elderly patients starting dialysis

Conditions: Chronic Kidney Disease; Endstage Renal Disease

Summary: this is a pilot, single-center, randomized trial of 90 subjects to evaluate complication rates and functional status decline in subjects age 65 years and older referred for vascular access placement. subjects will be randomized to arteriovenous fistula (avf) (n = 45) versus arteriovenous graft (avg) (n = 45), placed in a vascular access monitoring protocol, and undergo measurements of functional status including gait speed, grip strength, and self-reported function over 6 months. the primary hypothesis to be tested is that avf placement will result in a higher proportion of primary access failure as defined by a binary composite primary endpoint of an unsalvageable access or an immature access or a non-functional access measured at 6 months compared to avg placement. in addition, the study will evaluate whether avf placement and a greater number of access procedures will result in a greater decline in functional status as measured by the average change over 6 months in gait speed, grip strength, and self-reported function as assessed by the disabilities in arm, shoulder and hand survey.

the elderly population is the fastest growing segment of the dialysis population. a vascular access is required to perform dialysis and current guidelines support arteriovenous fistulas (avfs) over arteriovenous grafts (avgs) as the preferred vascular access for dialysis. however, the preferred choice of vascular access in the elderly is unclear. older adults have higher rates of complications from avf placement compared to avg placement. placement of a dialysis access and the procedures subsequently required to achieve and maintain access functionality could result in further declines of function in this already frail population and potentially reduce quality of life. high burdens of cardiovascular disease, heterogeneous life expectancy and variable health goals may make the ideal choice of vascular access different in the elderly population than the general dialysis population.

Eligibility criteria:
inclusion criteria: * age 65 years or older * referred by nephrology provider for vascular access for hemodialysis (hd) * able and willing to provide informed consent exclusion criteria: * patient is not a candidate for an avf per surgeon * congestive heart failure (chf) as defined by ejection fraction (ef) \< 20%, history of heart transplant, history of ventricular assist device * known central venous stenosis * metastatic cancer or active cancer receiving chemotherapy * multiple myeloma * vein mapping with arterial diameter ≤ 2mm and vein diameter ≤ 2.5mm or presence of stenosis or thrombosis in the draining vein * arterial flow velocity of ≤ 40ml/min

Keywords: arteriovenous fistula (avf) arteriovenous graft (avg)
integration of (isbirt) for teen drug use into a pediatric network

Conditions: Substance Use

Summary: the goal of this project is to integrate a previously-tested internet-facilitated screening, brief intervention, and referral to treatment (isbirt) system for adolescent substance use into a large network of primary care offices, the pediatric practices of children's hospital boston (ppoc).


Eligibility criteria:
inclusion criteria: * 12-18 year olds * coming for non-emergent care * access to a private computer * have email address exclusion criteria: * not available for follow-up questionnaires * unable to read or understand english at a 6th grade reading level * medically or emotionally unstable on the day of the visit

Keywords: cannabis abuse alcohol abuse substance abuse
ultrasonographic assessment of neck vessels as predictors of spinal anesthesia induced hypotension in elderly

Conditions: Post-spinal Hypotension

Summary: spinal anesthesia induces sympathetic blockade and venodilation, thus reducing venous return and the cardiac output. therefore, assessment of intravascular volume deficit before anesthesia might predict a critical decrease in blood pressure after anesthesia. recently, ultrasonographic evaluation of the internal jugular vein (ijv) has been used to reflect intravascular volume status and fluid and as a predictor of hypotension after induction of general anesthesia. carotid intima-media thickness (cimt) has been used to predict atherosclerosis-related events, such as stroke, myocardial infarction, peripheral artery disease, and hypotension after induction of anesthesia with a cut-off value of 0.65 mm of cimt as a threshold level.

this study aims to evaluate the ability of preoperative ultrasonographic assessment of the internal jugular vein (ijv) and carotid intima-media thickness (cimt) to predict spinal anesthesia induced hypotension (saih). participants will be elderly patients (above 60 years), asa i-ii-iii, scheduled for elective surgeries under spinal anesthesia.

Eligibility criteria:
inclusion criteria: * adult patients (\>60 years) * asa i-ii-iii * patients scheduled for elective surgeries under spinal anesthesia. exclusion criteria: * operations which will last for less than 15 minutes. * deep vein thrombosis in the upper extremities. * history of radiotherapy or neck surgery. * previous sonographic data show tricuspid or mitral regurgitation or a very distended right atrium and ventricle. * patients with history of valvular or carotid artery surgery, arrhythmia, heart failure. * being unable to lie in a supine position for the necessary measurements. * technical limitations to imaging of the ijv and carotid artery.
right ventricular damage in cardiovascular magnetic resonance

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to determine the predictors of right ventricular damage (rvd) assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement (de)cardiac magnetic resonance imaging in acute st-elevation myocardial infarction (stemi) and its prognostic significance. the investigators hypothesize that ischemia related changes of the myocardium are also visible in the right ventricle and that they have an impact on patient outcome.


Eligibility criteria:
inclusion criteria: * onset of symptoms \<12 h before angioplasty. * st-segment elevation of at least 0.1 mv in ≥2 extremity leads or at least 0.2 mv in ≥2 precordial leads. exclusion criteria: * contraindications to cmr as implanted defibrillators, pacemakers, ferromagnetic intracranial metallic implants or pulmonary metallic splints and claustrophobia. a further exclusion criterion was prior fibrinolysis.

Keywords: acute myocardial infarction right ventricular infarction cardiovascular magnetic resonance prognosis